Clinical Trials Management Associate

CTMA -Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.

Responsibilities:
Non-Client sponsored studies:

·Serves as the key operational contact with external investigators and internal stakeholders.

·Able to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety elements and implications.

·Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or Client product support are processed in a timely manner and to high quality.

·Proactively identifies operational challenges and in collaboration with senior team members provides and implements solutions to ensure study remains on track.

·Maintains efficient collaboration with company’s Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner.

·Supports study drug planning and shipping activities with Materials & Logistics.

·Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.

·Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.

·Provides monthly study updates to the appropriate internal stakeholders.

·Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.

·Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.

·Supports and implements Clinical Operations Quality Initiatives.

·Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.

·Performs administrative duties in a timely manner as assigned.

May contribute to Client sponsored studies:

·Monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.

·Under supervision may assist in development and review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.

·May assist in compilation of investigator brochures under close supervision.

·Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.

·Travel might be required.